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FDA to Decide on Antidepressant Warning
By DIEDTRA HENDERSON
AP Science Writer
WASHINGTON (AP) -- The Food and Drug Administration "within a few days" will decide on a stronger warning for antidepressants, a top official told Congress.
The agency is likely to follow recommendations of federal advisers who want black boxes, the most strident warnings, to highlight links between the drugs and increased suicidal thoughts and actions of children.
"We take this advice very seriously," said Dr. Robert Temple, director of the Office of Medical Policy within the FDA's Center for Drug Evaluation and Policy, on Thursday.
Temple spoke after an often contentious House Energy and Commerce investigations subcommittee hearing, but would not pinpoint a date for agency action.
"We've still got to write this stuff," he said.
Some grieving parents who attended the session were heartened by Temple's testimony that an agency decision is expected "within a few days."
Tom Woodward recommended that federal advisers demand the black box warnings in his testimony last week.
"I think it's long overdue," said Woodward, who blames his 17-year-old daughter's death on an anti-depressant she took for just seven days. "I think the senior leadership of the FDA has dragged their feet on this issue for too long."
Testifying before a House subcommittee, Temple said patients also would receive information guides with every prescription on how to balance the risk of suicide with the benefits of treating depression.
Also Thursday, a government epidemiologist said his bosses asked him to soften his recommendation that most anti-depressant use by children be discouraged because of increased suicidal behavior among young people who took the drugs.
During discussions with his managers in March, "alternative conclusions were offered to me, which I declined to incorporate into my written document," said Andrew Mosholder, who works in the FDA's Division of Drug Risk Evaluation.
Instead of discouraging the use of all but one anti-depressant, Prozac, for children, he was told to suggest that children use such medications "with caution," Mosholder told the subcommittee.
Mosholder said his reviews showed that Prozac, the only drug approved to treat depressed children, also posed the least risk.
It's standard for superiors to review conclusions to ensure they're supported by the evidence, countered Dr. Paul Seligman, acting director of the agency's Office of Drug Safety, outside the hearing room.
"That was done in this case. There was never any pressure to change what he wrote," Seligman said.
Mosholder told the panel that by last December his work confirmed his preliminary analysis that found that children taking Paxil and seven other antidepressants suffered increased suicidal thoughts and behavior more often than children taking sugar pills.
That finding was confirmed by an FDA senior reviewer who found that for every 100 children taking antidepressants in controlled clinical trials, an additional two to three experienced increased suicidal tendencies.
Mosholder said the FDA deferred action on his recommendations so it could confirm, through internal and external analyses, that the warning signs were legitimate.
Mosholder told the subcommittee that he was not allowed to present his findings at an FDA advisory meeting last February, and that he found himself one of the targets of an internal affairs investigation seeking the source of a leak to the media about those findings.
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On the Net:
FDA: http://www.fda.gov
© 2004 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Russia must iodise salt, UNICEF envoy Karpov says
Last Updated: 2004-09-23 14:27:05 -0400 (Reuters Health)
GENEVA (Reuters) - Russia and Ukraine must iodise all salt to protect their children from the risk of mental retardation, former world chess champion and UNICEF ambassador Anatoly Karpov said on Thursday.
Russia and Ukraine account for half of the 2.5 million babies born each year in the former Soviet Union and eastern Europe who are exposed to iodine deficiency, the leading cause of retardation, according to the U.N. Children's Fund (UNICEF).
"This is one of the few problems we know how to solve -- we must act strongly and quickly. It only costs five U.S. cents per person per year," Karpov told a news briefing in Geneva.
Only 48 percent of homes in Central and Eastern Europe, the Commonwealth of Independent States (CIS) and the Baltic States use iodised salt, according to UNICEF.
Karpov said there were hopeful signs the necessary political will was emerging in both countries. Draft legislation was being prepared in the State Duma, Russia's lower house of parliament, while Ukraine was weighing a presidential decree.
Iodine deficiency disorders can reduce intellectual capacity by 10 to 15 percent. The key is for women to consume iodine early in pregnancy when a fetus's brain cells develop.
"The most important consequence of iodine deficiency is brain damage," said Arnold Timmer, UNICEF nutrition officer.
"Once a child is born you can't fix that network of brain cells," he said.
Copyright © 2004 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
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